Efficacy Study of AlphaBRAIN Administered Orally

NCT ID: NCT02739139

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-09-30

Brief Summary

The manufacturers of AlphaBRAIN(TM) claim that their product, when taken as directed, has beneficial effects on cognition. The active ingredient in AlphaBRAIN, Huperzine A, is a naturally occurring compound found in firmoss and also thought to be an acetylcholinesterase inhibitor. Numerous clinical studies have been undertaken to investigate the effects of Huperzine A on cognition and have demonstrated benefit to cognition in both individuals diagnosed with neurodegenerative diseases as well as performance on academic tasks by students. However, to our knowledge, there are no randomized controlled trials evaluating the effects of AlphaBRAIN(TM) on cognition. Thus, the purpose of the current study is to assess the effects of daily oral administration of AlphaBRAIN(TM) on cognitive functioning, as compared to placebo, after 45 days of treatment.

1. To evaluate a single daily dose of AlphaBRAIN(TM) vs placebo given orally on the change in a battery of standardized neuropsychological tests (see attached).

2. A secondary objective is to evaluate a single daily dose of AlphaBRAIN(TM) vs placebo given orally on sleep.

Conditions

Cognitive Functioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

AlphaBrain

Intervention Type: DIETARY_SUPPLEMENT

Alpha BRAIN® (Onnit Labs LLC) is a multi-ingredient nutritional supplement that purports to enhance cognitive function in healthy adults. The commercially available product contains 12 naturally occurring compounds

AlphaBrain

AlphaBrain(TM)

Group Type: EXPERIMENTAL

AlphaBrain

Intervention Type: DIETARY_SUPPLEMENT

Alpha BRAIN® (Onnit Labs LLC) is a multi-ingredient nutritional supplement that purports to enhance cognitive function in healthy adults. The commercially available product contains 12 naturally occurring compounds

Interventions

AlphaBrain

Alpha BRAIN® (Onnit Labs LLC) is a multi-ingredient nutritional supplement that purports to enhance cognitive function in healthy adults. The commercially available product contains 12 naturally occurring compounds

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Community dwelling and can provide informed consent.
• MMSE score of ≥ 26.
• Body Mass Index within two standard deviations of the norm.
• Fluent in English.
• Willing to complete all study assessments.
• Adequate visual and auditory acuity to allow for neuropsychological testing.

Exclusion Criteria

• MMSE score < 26
• Body Mass Index greater then two standard deviations from the norm.
• Visual or Auditory disability which would interfere with neuropsychological testing.
• No past diagnosis of Stroke, ADD/ADHD, Learning Disability or Cardiac Condition.
• No current life threatening illnesses.
• Not currently (past 60 days) taking antidepressants or other psychoactive medications.
• Not currently taking any non-prescription cognitive enhancers (nutraceuticals or vitamins such as Ginko biloba.
• No history of alcohol or drug or dependence as defined by the DSM-IV-TR.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Onnits Labs, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Boston Center for Memory

Chestnut Hill, Massachusetts, United States

Countries

United States

Other Identifiers

AB-001

Identifier Type: -

Identifier Source: org_study_id